IASLC Grading System as a Predictor for EGFR-TKI Therapy

Lung Cancer Clinical Trial

Official title:

The IASLC Grading System as a Predictor for EGFR-TKI Therapy in EGFR-mutant Lung Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06131645
• Other study ID #: GRADS-TKI
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: December 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators previously validated the grading system proposed by International Association for the Study of Lung Cancer (IASLC) for invasive nonmucinous lung adenocarcinoma (LADC) for its reproducibility, prognostication function and predictive value of adjuvant chemotherapy (ACT). In this exploratory study, the investigators aimed to investigate the role of IASLC grading system in EGFR tyrosine kinase inhibitor (TKI) therapy selection either as adjuvant or palliative therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2160
• Est. completion date: July 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• invasive lung adenocarcinoma patients who underwent complete resection with positive EGFR mutations in exons 18-21.

Exclusion Criteria:

• adenocarcinoma in situ (AIS), minimally invasive adenocarcinoma (MIA), invasive mucinous adenocarcinoma and other variants of adenocarcinoma
• patients with pathologic slides unavailable for re-evaluation

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Diagnostic Test:
• IASLC grading system
A cohort of 2160 patients with invasive nonmucinous EGFR-mutant LADCs were retrospectively collected and classified according to the IASLC grading system. The role of IASLC grading system in EGFR tyrosine kinase inhibitor (TKI) therapy selection either as adjuvant or palliative therapy was investigated.

Locations

Country	Name	City	State
China	Chaoqiang Deng	Shanghai	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	DFS was defined as time from initiation of surgery to date of first event (recurrence or death)	5 years
Primary	Progression-free survival	PFS was defined as time from initiation of systemic palliative treatment to date of disease progression or death for 1L treatment of each patient and the initiation time was re-assigned additionally for each drug applied during the treatment history of the patients regardless of line of therapy (all lines)	5 years
Secondary	Overall survival	was defined as time from surgery to date of death resulting from any cause in ADJUVANT subgroup and from 1L systemic palliative treatment assignment to date of death resulting from any cause in RECURRENCE subgroup.	5 years